PEEP-induced Changed in RRI as Physiological Background of Ventilator-induced Kidney Injury (PRE-VIKI)

The renal Doppler resistive index (RRI) is a noninvasive tool that has been used to assess renal perfusion in the intensive care unit (ICU) setting. Many parameters have been described as influential on the values of renal RI. Mechanical ventilation is associated with significant increases in the risk of acute kidney injury (AKI). Ventilator-induced kidney injury (VIKI) is believed to occur due to changes in hemodynamics that impair renal perfusion. The investigators hypothesized that patients who need mechanical ventilation should have a different response in RRI when different levels of Positive end expiratory pressure (PEEP) are applied. Investigators wish to describe changing in RRI due to changes in PEEP and to verify whether these changes could partially explain the occurrence of VIKI

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Respiratory Distress Syndrome, Adult; Respiration, Artificial
• Intervention / Treatment: Procedure: PEEP changes

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44121
    • Università di Ferrara
  • Siena, Italy, 53100
    • Università di Siena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cohort of critically ill patients

Description

Inclusion Criteria:

• Patients admitted to ICU with expected mechanical ventilation >48h

Exclusion Criteria:

• Ultrasound RRI evaluation non available
• Patients with arrhythmia
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critically ill ventilated patients; Patients admitted to ICU with expected mechanical ventilation >48h	Procedure: PEEP changes; All patients will be ventilated with a tidal volume of 6 ml/kg before the RRI assessment. Further, three level of PEEP (5, 10 and 15 cmH2O) will be randomly set. For each levels of PEEP, the RRI will be evaluated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of AKI	AKI will be defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria	once a day until day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in RRI at different level of PEEP	To compare median difference of RRI at PEEP 5 and PEEP 15 in patients who will develop (or not) AKI	One a day until day 5

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Kidney Diseases; Urologic Diseases; Infant, Newborn, Diseases; Renal Insufficiency; Lung Injury; Infant, Premature, Diseases; Wounds and Injuries; Acute Kidney Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: RRIPEEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared under reasonable request to the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No